ULTRABRAID 72203852Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00885554030037), received between Sep 14, 2017 and Jun 25, 2025 — classified as 18 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, IT WAS NOT POSSIBLE TO PLACE THE SUTUREFIX IMPLANT DUE TO A THREAD BREAKAGE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328877 ↗
• MalfunctionJun 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE SUTUREFIX ULTRA SUTURE WITH NEEDLE CAME LOOSE FROM THE IMPLANT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144047 ↗
• MalfunctionAug 21, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE SUTUREFIX BROKE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20020829 ↗
• MalfunctionNov 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SETUP WHEN THE BOX OF THE SUTTERFIX WAS OPEN, IT WAS NOTICED THAT THE IMPLANT AND THREAD WERE SEPARATED. THERE WAS A BACK-UP DEVICE AVAILABLE AND A DELAY LESS THAN 30 MINUTES REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234094 ↗
• MalfunctionNov 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SETUP WHEN THE BOX OF THE SUTTERFIX WAS OPEN, IT WAS NOTICED THAT THE IMPLANT AND THREAD WERE SEPARATED. THERE WAS A BACK-UP DEVICE AVAILABLE AND A DELAY LESS THAN 30 MINUTES REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234060 ↗
• InjuryOct 31, 2023Break; Break

  IT WAS REPORTED THAT DURING A MPFL RECONSTRUCTION, 1CM OF THE METAL INSERTER OF THE SUTUREFIX ULTRA BROKE OFF WITH THE IMPLANT INSIDE THE PATIENT. THE BROKEN PIECES AND THE IMPLANT WERE REMOVED FROM THE PATIENT USING TWEEZERS. A VOID WAS LEFT IN THE PATIENT'S BONE AND A NEW HOLE HAD TO BE DRILLED IN ORDER TO USE THE BACK-UP DEVICE. THE PROCEDURE WAS COMPLETED WITH A 5 MINUTES SURGICAL DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 18044160 ↗
• InjuryMay 10, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE SUTUREFIX ULTRA ANCHOR DID NOT TAKE THE DESIRED POSITION, AND THE THREADS GOT SEPARATED FROM THE ANCHOR. BOTH THE ANCHOR AND THE SUTURES WERE REMOVED FROM THE PATIENT WITH GRASPERS. SURGERY WAS COMPLETED WITHOUT DELAY, USING A BACK-UP DEVICE IN AN ADDITIONALLY DRILLED BONE HOLE, THE ORIGINAL HOLE WAS NOT FILLED WITH BONE GRAFT, THEREFORE, A VOID WAS LEFT ON THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S EVOLUTION IS EXCELLENT.

  Patient problems: Perforation; Rupture

  MAUDE report 16901790 ↗
• InjuryMay 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CUFF SUTURE + INSTABILITY PROCEDURE, THE SUTUREFIX ANCHOR FAILED WHEN PERFORMING THE SUTURE, THE ANCHOR DETACHED FROM THE BONE. THE SURGEON DETERMINE TO NOT PERFORM THE STABILITY DUE TO VERY OSTEOPOROTIC BONE; HOWEVER, THE CUFF SUTURE WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 16899148 ↗
• InjuryFeb 20, 2023Break; Break

  IT WAS REPORTED THAT AFTER A PROCEDURE THE SURGEON OBSERVED A METAL PIECE OF THE DISTAL TIP OF THE SUTUREFIX ULTRA WAS LEFT IN THE BONE OF THE PATIENT. THE PIECE WAS LEFT IN THE BONE OF THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16406304 ↗
• InjuryNov 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING IMPLANTATION FIVE (5) SUTUREFIX ULTRA ANCHOR´S WERE USED, AND ONE THE METAL INSERTER TIP SHEARED OFF INSIDE THE PATIENT´S GLENOID, ALTHOUGH IT IS UNKNOWN WHICH ONE OF THE FIVE REPORTED DEVICES; THIS ISSUE WAS NOT VISIBLE WHEN IMPLANTED AND THE ITEM IS UNDERNEATH THE REPAIRED LABRUM INSIDE THE BONE. THE METAL WAS NOTICED ON SECOND LOOK IMAGING IN THE PHYSICIAN´S OFFICE. SURGERY WAS COMPLETED WITH THE REPORTED DEVICES WITHOUT ANY DELAY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15786518 ↗
• InjuryJul 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE, AFTER ALL THE CORRECT USE OF THE TECHNIQUE FOR IMPLANTATION OF THE SUTUREFIX ULTRA ANCHOR, THERE WAS NO FIXATION IN THE BONE AND IT LOOSENED. THE ANCHOR CAME OUT ALONG WITH THE ANCHOR WIRE AND IT WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY USING A BACK-UP DEVICE IN AN ADDITIONAL DRILL HOLE. THE FIRST HOLE WAS LEFT VOID AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 14940698 ↗
• InjuryApr 13, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, WHEN THE DOCTOR INSERTED THE SUTUREFIX INTO THE DRILL GUIDE HE FELT SOMETHING WRONG, WHEN DEPLOYING THE ANCHOR A METAL PIECE WAS LOOSE IN THE TOP, THE MOST DISTAL PART OF THE INSERTER "FELL OFF", THE PART WAS REMOVED. INSTRUMENT SIZE TO PREPARE THE INSERTION SIZE WAS 1,7MM SUTUREFIX DRILL. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THE BACK UP DEVICE WAS USED IN THE ORIGINAL BONE HOLE, THERE WAS NO VOID LEFT IN THE PATIENT. THERE WAS A NON-SIGNIFICANT DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14091975 ↗
• InjuryOct 14, 2021Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR PROCEDURE, PART OF THE INTERNAL DEPLOYMENT MECHANISM OF THE SUTUREFIX ULTRA BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT WITH ARTHROSCOPIC GRASPERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY BONE HOLE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12631465 ↗
• InjuryAug 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE SUTURE FIX ANCHORS PULLED OUT. A NEW BONE HOLE WAS DRILLED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. THE PATIENT CURRENT STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 12375048 ↗
• InjuryAug 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE SUTURE FIX ANCHORS PULLED OUT. A NEW BONE HOLE WAS DRILLED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. THE PATIENT CURRENT STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 12375033 ↗
• InjuryAug 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE SUTURE FIX ANCHORS PULLED OUT. A NEW BONE HOLE WAS DRILLED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. THE PATIENT CURRENT STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 12340512 ↗
• InjuryAug 17, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE SUTUREFIX ULTRA WAS FOUND TO BE DEFECTIVE. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND IF A DELAY OCCURRED. HOWEVER, NO PATIENT INJURIES WERE REPORTED. TWO DEVICES ARE INVOLVED FOR THIS CASE (LOT 1: 2065057 AND LOT 2: UNK) AND IT IS UNKNOWN WHICH LOT NUMBER BELONGS TO EACH MALFUNCTION. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT ONE OF THE DEVICES HAD THE SUTUREFIX FORK FRACTURED LEAVING THE ANCHOR HANGING FROM THE DISTAL TIP WITH DEBRIS WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12334263 ↗
• InjuryJun 15, 2021Break; Break

  IT WAS REPORTED THAT A SUTUREFIX ULTRA AHR S 2 UB STR BLUE WAS USED INSIDE THE PATIENT DURING ARTHROSCOPY PROCEDURE AND WHEN THE SURGEON CHECKED IMMEDIATELY AFTER THE SURGERY, IT WAS FOUND THAT A METAL PIECE WAS LEFT IN THE GLENOID. THE PIECE WAS NOT REMOVED FROM THE PATIENT. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 12001061 ↗
• InjuryJan 8, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE SUTUREFIX INSERTER BROKE AFTER THE ANCHOR WAS IMPLANTED. THE BROKEN PIECE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11143407 ↗
• MalfunctionNov 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT HAD A BANKART REPAIR AND CAPSULAR STABILIZATION SURGERY WHERE A "1.7MM SUTUREFIX ULTRA ANCHOR WAS IMPLANTED TO HIM. HOWEVER, AFTER THIS SURGERY, THE PATIENT HAD RECURRENT INSTABILITY AND ON (B)(6) 2020 BEGAN EXPERIENCING A RECURRENT LEFT SHOULDER DISLOCATION ON TRIVIAL INJURY. AS A RESULT, THE PATIENT WENT UNDER A REVISION SURGERY (OPEN LATERJET PROCEDURE) ON (B)(6) 2020 FOR SHOULDER REPAIR AND IS CURRENTLY RECOVERING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10819746 ↗
• MalfunctionNov 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT HAD A BANKART REPAIR AND CAPSULAR STABILIZATION SURGERY WHERE A "1.7MM SUTUREFIX ULTRA ANCHOR WAS IMPLANTED TO HIM. HOWEVER, AFTER THIS SURGERY, THE PATIENT HAD RECURRENT INSTABILITY AND ON (B)(6) 2020 BEGAN EXPERIENCING A RECURRENT LEFT SHOULDER DISLOCATION ON TRIVIAL INJURY. AS A RESULT, THE PATIENT WENT UNDER A REVISION SURGERY (OPEN LATERJET PROCEDURE) ON (B)(6) 2020 FOR SHOULDER REPAIR AND IS CURRENTLY RECOVERING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10819745 ↗
• MalfunctionNov 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT HAD A BANKART REPAIR AND CAPSULAR STABILIZATION SURGERY WHERE A "1.7MM SUTUREFIX ULTRA ANCHOR WAS IMPLANTED TO HIM. HOWEVER, AFTER THIS SURGERY, THE PATIENT HAD RECURRENT INSTABILITY AND ON (B)(6) 2020 BEGAN EXPERIENCING A RECURRENT LEFT SHOULDER DISLOCATION ON TRIVIAL INJURY. AS A RESULT, THE PATIENT WENT UNDER A REVISION SURGERY (OPEN LATERJET PROCEDURE) ON (B)(6) 2020 FOR SHOULDER REPAIR AND IS CURRENTLY RECOVERING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10819730 ↗
• InjuryOct 23, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE ANCHOR OF ULTRABRAID SUTURE DETACHED FROM THE INCISION SITE, THEREFORE, IT HAS TO BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A Q-FIX. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10723745 ↗
• InjuryOct 23, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE ANCHOR OF ULTRABRAID SUTURE DETACHED FROM THE INCISION SITE. IT WAS REQUIRED TO DRILL AGAIN TO PLACE ANOTHER ANCHOR AND THE SAME THING HAPPENS, BOTH ANCHORS WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A Q-FIX. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10723708 ↗
• InjuryOct 8, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, WHEN INTRODUCING THE "1.7MM SUTUREFIX ANCHOR" FOLLOWING THE RECOMMENDED SURGICAL TECHNIQUE, AFTER PULLING THE ANCHOR IT DID NOT FIX. THEN, WHEN REMOVING THE GUIDE, THE SURGICAL STAFF NOTED THAT THERE WAS A 3MM METALLIC PIECE LOOSE AT THE JOINT. THE METALLIC PIECE WAS REMOVED WITH GRASPER FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10653398 ↗